Comparing robotic and endo-laparoscopic methods for difficult gallstone removal
Randomized Trial Comparing One-stage Robotic Approach Versus Two-stage Endo-laparoscopic Approach for Difficult Choledocholithiasis (REAL Trial)
This study is testing whether robotic surgery or endo-laparoscopic surgery works better for people with stubborn gallstones that haven't improved with regular treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05611840 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of robotic surgery versus endo-laparoscopic surgery in treating difficult choledocholithiasis, a condition where gallstones obstruct the common bile duct. The study involves patients who have not responded to standard endoscopic treatments and aims to determine which surgical approach yields better outcomes. Participants will undergo either robotic or endo-laparoscopic procedures, with their recovery and success rates monitored and compared. The trial is designed to provide clearer guidance on the best surgical options for patients facing this challenging condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with difficult choledocholithiasis who have not undergone cholecystectomy and are fit for general anesthesia.
Not a fit: Patients with a history of recurrent pyogenic cholangitis or those who have experienced complications from previous ERCP procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients with difficult choledocholithiasis.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of surgical versus endoscopic approaches for choledocholithiasis, making this trial's comparative analysis particularly relevant.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Definitions of difficult CBD stone: stone size \> 1.5cm, and/or multiple stones \> 3, and/or narrow and angled distal common bile duct (CBD) (\< 1350) * Diagnostic ERCP with successful CBD deep cannulation and temporarily CBD stenting * No history of cholecystectomy * General condition fit for GA Exclusion Criteria: * History of recurrent pyogenic cholangitis * Failed endoscopic biliary stenting by initial ERCP * Complications of ERCP (severe necrotizing pancreatitis, papillotomy bleeding or bowel perforation) * Previous upper abdominal surgery, including gastrectomy * General condition unfit for GA
Where this trial is running
Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Kelvin Ng, PhD — Chinese University of Hong Kong
- Study coordinator: Kelvin Ng, PhD
- Email: kelvinng@surgery.cuhk.edu.hk
- Phone: (852)35051496
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.